Compliance and Validaton Consulting for a CRO
Provided technical consulting services and developed, implemented and executed a critical validation program for a Clinical Research Organization. The program was in response to compliance audit findings identified by one of the client's potential customers during an audit. Initially, the validation program was executed for a clinical trial data management system and statistical analysis software. The implementation of this program secured a very large contract for the company. As part of the project, 10 additional systems were validated.
- Provided flexibility to meet customer’s aggressive execution schedule and accommodate their customer’s busy schedule
- IPS experts assessed the issues and provided recommendations that captured the client’s confidence and enabled their executive team to focus on the core business
- Well-organized and comprehensive deliverables successfully passed numerous audits with little or no findings
- Aligned with the customer’s business plan to develop a program that brought the “best value”
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